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NCT02410707 · ClinicalTrials.gov registry record · NA
Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults
A NA study of Abscess and Joint Dislocation, sponsored by Albert Einstein Healthcare Network.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT02410707: Completed NA study of Abscess and Joint Dislocation, sponsored by Albert Einstein Healthcare Network.
NCT02410707 is a NA study of Abscess and Joint Dislocation that has completed, run by Albert Einstein Healthcare Network. The registered enrollment target is 43 participants, below the 387-participant average among 13 other Abscess trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02410707, a NA study of Abscess and Joint Dislocation, has completed, sponsored by Albert Einstein Healthcare Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.
Primary Outcome
End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds
Conditions Studied
Interventions
- DRUG Oxygen
- DRUG Propofol
- DRUG Nitrous Oxide arm
Study Locations (1)
Pennsylvania
- Albert Einstein Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-02 |
| Phase | NA |
What the finished NCT02410707 record still lists
NCT02410707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 387-participant average among 13 other Abscess trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Abscess appearing as the primary indexed condition, and to 3 interventions - of which Oxygen is the first listed.
NCT02410707 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02410707 about?
NCT02410707 is a clinical study titled "Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults". The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to r...
What is the current status of trial NCT02410707?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2015-02. Estimated completion is 2018-02.
What conditions does trial NCT02410707 study?
This clinical trial studies the following conditions: Abscess, Joint Dislocation, Perianal Abscess.
What interventions are being tested in trial NCT02410707?
The interventions under investigation include: Oxygen (DRUG), Propofol (DRUG), Nitrous Oxide arm (DRUG).
Who is sponsoring clinical trial NCT02410707?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02410707 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Abscess
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02410707's enrollment target sits among peer trials
43 11th of 13 higher than 3 of 13 other Abscess trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abscess trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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